Latest Biotech News

The FDA approved Moderna’s seasonal influenza mRNA vaccine (mRNA-1010, mFLUSIVA) for adults, marking the first FDA clearance for an mRNA flu shot in the U.S. The approval followed a unanimous...

Alamar Biosciences reported a sharp revenue rebound in its first full quarter as a public company, alongside an expansion of a large-scale plasma proteomics collaboration tied to Alzheimer’s. In...

Sionna Therapeutics ended its cystic fibrosis add-on strategy after a Phase 2 trial failed to show benefit when paired with Vertex’s Trikafta. In the Precision CF study, Sionna’s SION-719 plus...

Silence Therapeutics announced Phase 2 success for divesiran in polycythemia vera, setting up a move into Phase 3 for the gene-silencing therapy. In the 48-patient trial, Silence said 88% of...

Jazz Pharmaceuticals agreed to acquire Actio Biosciences in a deal that could total more than $1.3 billion, adding a clinical-stage precision therapy targeting KCNT1-related epilepsy. Under the...

U.S. lawmakers are advancing a proposed trial-reform approach that would embed clinical research into routine care to speed up first-in-human study starts. The effort, linked to a “Hauchincloss”...

Qiagen received FDA clearance for a gram-positive bacterial and fungal bloodstream infection test that runs on the QiaStat-Dx platform, extending the company’s BCID assay menu in the U.S. The...

Labcorp said the FDA approved PGDx elio tissue complete as a companion diagnostic for BRAF V600E and V600K mutations in melanoma, expanding access to mutation testing that guides targeted...

FDA rejected ITM Isotope Technologies Munich’s radiopharmaceutical therapy candidate for neuroendocrine tumors after manufacturing problems surfaced during review. The decision delays a potential...

AbCellera reported Phase 2 results for a NK3R-targeting therapy in vasomotor symptoms, positioning its program to compete for share in the hot-flash treatment market. The company’s shares rose...

The FDA approved Moderna’s seasonal mRNA flu vaccine, mRNA-1010 (mFLUSIVA), marking the first mRNA flu shot cleared in the U.S. for adults aged 50–64. The decision followed a unanimous VRBPAC...

CMS launched details of the Medicare GLP-1 Bridge program, creating a flat $50 monthly copay signal for eligible Medicare Part D beneficiaries seeking certain weight management drugs through a...

Cystic fibrosis challenger Sionna Therapeutics disclosed that its Phase 2 add-on strategy failed to improve sweat chloride versus Vertex’s Trikafta alone, sending shares down sharply and removing...

Bristol Myers Squibb selected Houston for a new $2.3 billion multi-modal manufacturing campus designed to support drug product and finished goods manufacturing from late development through...

The FDA approved Labcorp’s PGDx elio tissue complete as a companion diagnostic for detecting BRAF V600E and V600K mutations in melanoma, enabling patient selection for FDA-approved targeted...

Broken String Biosciences launched BaseMap ABE, a platform for genome-wide off-target characterization supporting adenine base editing therapeutic development. The company says BaseMap ABE...

Natera said it is expanding Signatera’s footprint in minimal residual disease testing and preparing to enter early cancer detection after multiple recent regulatory wins. In the last four months,...

Jazz Pharmaceuticals agreed to acquire Actio Biosciences in a deal worth up to $1.3 billion, including $820 million upfront and up to $500 million in contingent payments tied to milestones. The...

Digital Science launched two Model Context Protocol (MCP) servers for its Dimensions research platform, aimed at giving enterprise AI agents direct access to a connected database of scientific and...

The FDA rejected ITM Isotope Technologies Munich’s radiopharmaceutical candidate ITM-11 for neuroendocrine tumors due to manufacturing problems, according to the company. The decision delays a...